Stroke Clinical Trial - Improving Diagnosis & Prediction of Outcome in

Status Recruiting

Clinical Trial Summary

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

Clinical Trial Description

In order to identify patients with a good neurological outcome a combination of diagnostic tests is used. Clinical rating scales - Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score - Once a week Blood biomarkers - Neuron specific enolase, neurofilament light, glial fibrillary acidic protein - Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury - Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C EEG with reactivity testing - Standard 21-electrode montage - Stimuli protocol I: a set of 5 stimuli repeated 3 times 1. Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds - Stimuli protocol II: Cognitive-motor dissociation test MRI-scan - Sequences considered essential for patient care i.e.T1, T2, FLAIR, DWI/SWI - Preferably, performed between 4-6 weeks after hospital admission ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06283901
Study type	Observational
Source	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact	Wolmet Haksteen, MD
Phone	+31 020 566 9111
Email	w.e.haksteen@amsterdamumc.nl
Status	Recruiting
Phase
Start date	January 2, 2023
Completion date	September 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness — IMPROVE-DOC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms